Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published on February 28, 1992 and are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements. CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance, as applicable.

PARTIAL SUMMARY FINAL RULE This summary is for informational purposes only, is not comprehensive, focuses primarily on general and special chemistry, hematology and virology requirements and not intended to be used as a guide for achieving compliance.

The Joint Commission on Accreditation of Healthcare Organizations Homepage. The mission of the Joint Commission on Accreditation of Healthcare Organizations is to improve the quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations. The Joint Commission evaluates and accredits more than 19,500 health care organizations in the United States, including hospitals, health care networks, managed care organizations, and health care organizations that provide home care, long term care, behavioral health care, laboratory, and ambulatory care services.

The National Committee for Clinical Laboratory Standards Homepage. NCCLS is a globally recognized, voluntary consensus standards-developing organization that enhances the value of medical testing within the healthcare community through the development and dissemination of standards, guidelines, and best practices.

Laboratory Practice and Quality

Dr. James Westgard Homepage: Tools, technology and training for quality management in healthcare laboratories. Articles on QC and lab quality, continuing education, online course: "QC Planning for Healthcare Laboratories", offered by the American Association for Clinical Chemistry (AACC), a cource about figuring out what amount of QC is necessary to assure the desired quality will be achieved for the methods in your laboratory. This course is intended for clinical laboratory scientists who have an interest in or responsibility for technical quality management of laboratory testing processes.

Private Office Laboratories: Coping With Federal Guidelines By Ira Schwartz, MD, PhD, The Hospital of The University of Pennsylvania. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) mandated that all laboratory testing in the US come under regulation by the Health Care Financing Administration. Congress enacted this law to safeguard the public. Physician office laboratories run by urologists are included in these regulations. Noncompliance affects Medicare and Medicaid reimbursements.